Serialization is the process of assigning and applying a unique identification code to a product. Aggregation defines the relationship between multiple items within a product shipment, such as cartons, cases, and pallets. Together, these two concepts form the foundation of “Track-and-Trace,” which documents a product’s current and past locations throughout the supply chain. This ability to track a product’s whereabouts and trace its path is the start of a safer and more efficient drug supply chain.
The implementation of serialization is today one of the biggest challenges in the pharmaceutical industry. The list of requirements is long and can range from coding of single items to the central management of multiple packaging lines or sites.
In addition to the necessary printing and camera technology to allow efficient and reliable coding and verification of secondary packages including aggregation, the integration of appropriate software and database applications over all ISA95 levels is the key to ensure a successfull and sustainable track & trace strategy.
The aggregation of pharmaceutical products for tracking purposes is already compulsory in some countries and expected for others too. Logistical reasons can also require aggregation even without explicit regulation e.g. in order to register the codes that are released into the market at the warehouse.
For the aggregation of single items to bundles, cases or pallets camera systems and label printers need to be integrated into existing case packers. A connection to a central software allows that the aggregated hierarchies can be recorded, saved and administrated efficiently. For a stable process the data are collected in real time at the module and transferred to a line or site server. For smaller batches the procedure may also be carried out by means of a so-called manual aggregation table with code scan camera that is able to transfer the data to a server.
Reliable serialisation and labelling systems for the manufacturers of pharmaceutical products can put an end to the very serious global trade in illegal drugs once and for all. With 2011/62/EU Directive, the European Union has brought the initiative to combat the life threatening counterfeiting of medicinal products irrevocably closer to victory. The prerequisite for safeguarding against falsified medicines is the assignment of a unique serial number linked to the individual production data (product identification GTIN/NTIN/PPN, expiry date, and batch number) in the form of a Data Matrix Code. The distinctive "branding" by the pharmaceutical industry in conjunction with sealed labels on the packaging ensures the authenticity and integrity of a drug unit and protection from tampering. Traceability is an essential key to safe drugs and the basis for absolute confidence on the part of the consumer in the pharmaceutical industry and its products.
Smart camera vision systems such as the Cognex In-Sight 5605® 5MP are a small, but critical component used extensively in the serialization solution, not only to validate the presence, accuracy, and readability of the various labels, but also to ensure product safety and package integrity.
CPO companies have multifunctional system developed by Vision for packaging inspection was originally conceived as a basic optical character recognition instrument. Year by year this inspection system has turned into a packaging inspection top-performing solution, able to perform with the highest flexibility several customized types of packaging inspection for every needs, both on the cosmetic packaging aspect and on codes/characters printed on the product.
The software structure is modular and scalable: software functions can be added over time as individual controls are associated with specific licenses for dedicated packaging inspection applications. In order to simplify the system programming, It has an auto-programming wizard that guides the operator during working format management.